Fast‑Track AXPAXLI

The FDA alignment centers on a 505(b)(2) pathway, which could accelerate the review timeline by up to 60 days. Ocular has also added a new secondary endpoint to SOL‑R to evaluate superiority of AXPAXLI versus aflibercept (8 mg) Q6M at Week 96, potentially positioning AXPAXLI as a best‑in‑disease agent. The SOL‑R trial will remain masked through Week 96, with top‑line results expected in the first quarter of 2028.